MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-07 for VERIFY 3531 manufactured by Medtronic Neuromodulation.
[69496665]
The main component of the system and other applicable components are: product id 3057, serial # unknown, product type screening device.
Patient Sequence No: 1, Text Type: N, H10
[69496666]
Information was received from a consumer? S family regarding a trial patient. It was reported the stim was turned off on its own during the night. It was indicated that there were unknown environmental, external, or patient factors that may have led or contributed to the issue. The issue was not resolved at time of the report. A day later, it was further reported that patient broke off her lead during the night. There was no patient symptoms or complication associated with the event. Patient status was noted as alive, no injury. Patient had basic evaluation trial started on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
[69582698]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[100944852]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2017-00871 |
| MDR Report Key | 6383580 |
| Date Received | 2017-03-07 |
| Date of Report | 2017-03-07 |
| Date of Event | 2017-02-08 |
| Date Mfgr Received | 2017-03-07 |
| Date Added to Maude | 2017-03-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | MEDTRONIC NEUROMODULATION |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 554211200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 554211200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERIFY |
| Generic Name | SELECTOR, SIZE, OSTOMY |
| Product Code | EXA |
| Date Received | 2017-03-07 |
| Model Number | 3531 |
| Catalog Number | 3531 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-07 |